Sorin Connect

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K170460 ↗

FDA Product Code

DXJ

Device Class

Class II

Regulation

21 CFR Part 870.2450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Flextherm

  Class II

  FDA 510(k) K140012 Active Cleared 31 Jan 2014

See all devices from Sorin Group Deutschland GmbH →

• What is the Sorin Connect used for in cardiac surgery?

  The Sorin Connect is a software-based system designed to record, process, and evaluate perfusion data during cardiopulmonary bypass procedures. It captures real-time or manually entered clinical metrics—such as flow rates, oxygen saturation, and temperature—to support intraoperative monitoring and analysis, helping clinicians optimize patient outcomes during cardiac surgery.

• How is the Sorin Connect supplied and what devices does it interface with?

  The Sorin Connect is supplied as a standalone software platform and is intended for use with Sorin/Stöckert heart-lung machines. It interfaces directly with these devices to automate or facilitate manual data input for perfusion parameters, ensuring seamless integration into the operating room workflow.

• Is the Sorin Connect sterile, single-use, or reusable?

  The Sorin Connect is a non-sterile, reusable medical device. Since it is a software-based system, sterility is not applicable, and it is designed for repeated use in hospital settings following standard clinical IT protocols.

• Does the Sorin Connect require any special storage or environmental conditions?

  The Sorin Connect adheres to standard clinical IT protocols for medical software storage and usage. As a non-sterile, reusable device, it should be stored in a clean, controlled environment—such as a hospital’s IT or medical device storage area—following manufacturer guidelines to maintain system integrity and prevent contamination.

• What regulatory pathway does the Sorin Connect follow?

  The Sorin Connect is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K170460. It is classified as a Class II device (product code DXJ) and is intended for use in cardiopulmonary bypass procedures, ensuring compliance with cardiovascular medical device standards.